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Pivotal Study in Advanced Parkinsons Disease Patients

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pramipexol Extended Release
Pramipexol Immediate Release
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

32 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
  2. Parkinsons disease diagnosed for at least 2 years.
  3. Patients 30 years of age or older at the time of diagnosis.
  4. Modified Hoehn and Yahr stage of 2 to 4 at on-time.
  5. Treatment with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor, or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit.
  6. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit).
  7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary.
  8. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation).

Exclusion Criteria:

  1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
  2. Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
  3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study
  4. History of psychosis, except history of drug induced hallucinations
  5. History of deep brain stimulation
  6. Clinically significant Electrocardiogram abnormalities at screening visit
  7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
  8. Malignant melanoma or history of previously treated malignant melanoma
  9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
  10. Pregnancy or breast-feeding
  11. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study period
  12. Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal
  13. Patients with a creatinine clearance < 50 millilitres/minute
  14. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
  15. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
  16. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
  17. Flunarizine within 3 months prior to baseline visit
  18. Known hypersensitivity to pramipexole or its excipients
  19. Drug abuse according to investigators judgement, within 2 years prior to screening
  20. Participation in other investigational drug studies, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit

Sites / Locations

  • 248.525.43005 Boehringer Ingelheim Investigational Site
  • 248.525.42003 Boehringer Ingelheim Investigational Site
  • 248.525.42001 Boehringer Ingelheim Investigational Site
  • 248.525.42005 Boehringer Ingelheim Investigational Site
  • 248.525.42002 Boehringer Ingelheim Investigational Site
  • 248.525.42004 Boehringer Ingelheim Investigational Site
  • 248.525.36005 Boehringer Ingelheim Investigational Site
  • 248.525.36003 Boehringer Ingelheim Investigational Site
  • 248.525.36006 Boehringer Ingelheim Investigational Site
  • 248.525.36004 Boehringer Ingelheim Investigational Site
  • 248.525.91004 National Institute of Mental Health & Neuro Sciences
  • 248.525.91002 Apollo Hospital
  • 248.525.91001 Institute of Human Behaviour & Allied Sciences
  • 248.525.91003 Nizam's Institute of Medical Sciences
  • 248.525.91007 Boehringer Ingelheim Investigational Site
  • 248.525.91005 Mallikatta Neuro Research Center
  • 248.525.91006 King Edward Memorial Hospital & Research Centre
  • 248.525.39001 Policlinico di Catania
  • 248.525.39010 Campus Universitario Germaneto
  • 248.525.39009 Ce.S.I.
  • 248.525.39007 Ospedale della Misericordia
  • 248.525.39002 Università Federico II
  • 248.525.39008 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
  • 248.525.39005 Università La Sapienza di Roma
  • 248.525.39011 Policlinico Tor Vergata
  • 248.525.82001 Boehringer Ingelheim Investigational Site
  • 248.525.82008 Boehringer Ingelheim Investigational Site
  • 248.525.82007 Boehringer Ingelheim Investigational Site
  • 248.525.82002 Boehringer Ingelheim Investigational Site
  • 248.525.82003 Boehringer Ingelheim Investigational Site
  • 248.525.82004 Boehringer Ingelheim Investigational Site
  • 248.525.82005 Boehringer Ingelheim Investigational Site
  • 248.525.82006 Boehringer Ingelheim Investigational Site
  • 248.525.63210 Makati Medical Center
  • 248.525.63202 Chinese General Hospital
  • 248.525.63205 Jose Reyes Memorial Medical Center
  • 248.525.63206 Metropolitan Medical Center
  • 248.525.63207 Manila Doctors Hospital
  • 248.525.63201 The Medical City
  • 248.525.63204 St Lukes Medical Center
  • 248.525.63208 University of the East Ramon Magsaysay Memorial Medical Ctr
  • 248.525.48001 Boehringer Ingelheim Investigational Site
  • 248.525.48003 Boehringer Ingelheim Investigational Site
  • 248.525.48002 Wolski Hospital Dr. Anna Gostynska
  • 248.525.07001 Boehringer Ingelheim Investigational Site
  • 248.525.07002 Boehringer Ingelheim Investigational Site
  • 248.525.07003 Boehringer Ingelheim Investigational Site
  • 248.525.07004 Boehringer Ingelheim Investigational Site
  • 248.525.07007 Boehringer Ingelheim Investigational Site
  • 248.525.07005 Boehringer Ingelheim Investigational Site
  • 248.525.07006 Boehringer Ingelheim Investigational Site
  • 248.525.42104 Boehringer Ingelheim Investigational Site
  • 248.525.42105 Boehringer Ingelheim Investigational Site
  • 248.525.42103 Boehringer Ingelheim Investigational Site
  • 248.525.42101 Boehringer Ingelheim Investigational Site
  • 248.525.34001 Boehringer Ingelheim Investigational Site
  • 248.525.34003 Boehringer Ingelheim Investigational Site
  • 248.525.34004 Boehringer Ingelheim Investigational Site
  • 248.525.34005 Boehringer Ingelheim Investigational Site
  • 248.525.34002 Boehringer Ingelheim Investigational Site
  • 248.525.34008 Boehringer Ingelheim Investigational Site
  • 248.525.46005 Boehringer Ingelheim Investigational Site
  • 248.525.46002 Boehringer Ingelheim Investigational Site
  • 248.525.46001 Boehringer Ingelheim Investigational Site
  • 248.525.46004 Boehringer Ingelheim Investigational Site
  • 248.525.38003 Boehringer Ingelheim Investigational Site
  • 248.525.38006 Boehringer Ingelheim Investigational Site
  • 248.525.38002 Boehringer Ingelheim Investigational Site
  • 248.525.38004 Boehringer Ingelheim Investigational Site
  • 248.525.38005 Boehringer Ingelheim Investigational Site
  • 248.525.38001 Boehringer Ingelheim Investigational Site
  • 248.525.44005 Boehringer Ingelheim Investigational Site
  • 248.525.44007 Boehringer Ingelheim Investigational Site
  • 248.525.44002 Boehringer Ingelheim Investigational Site
  • 248.525.44004 Boehringer Ingelheim Investigational Site
  • 248.525.44003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Placebo Comparator

Arm Label

Pramipexole ER

Pramipexole IR

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Secondary Outcome Measures

Change From Baseline in Percentage Off-time at Week 18
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Clinical Global Impression - Global Improvement (CGI-I) Responder
CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)
Response in Patient Global Impression (PGI-I)
PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)
Change From Baseline in UPDRS I Score After 18 Weeks
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period
UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.
Change From Baseline in UPDRS III Score After 18 Weeks
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Change From Baseline in UPDRS IV Score After 18 Weeks
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks
ranging from 0 (best case) to 63 (worst case)
Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks
ranging from 0 (worst case) to 150 (best case)
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks
Ranging from 0 (best case) to 156 (worst case)
Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks
ranging from 0 (worst case) to 100 (best case)
Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18
Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)

Full Information

First Posted
April 25, 2007
Last Updated
June 24, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00466167
Brief Title
Pivotal Study in Advanced Parkinsons Disease Patients
Official Title
A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done. The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
517 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pramipexole ER
Arm Type
Other
Arm Title
Pramipexole IR
Arm Type
Other
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pramipexol Extended Release
Intervention Type
Drug
Intervention Name(s)
Pramipexol Immediate Release
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
Description
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Time Frame
baseline and week 18
Secondary Outcome Measure Information:
Title
Change From Baseline in Percentage Off-time at Week 18
Description
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Time Frame
baseline and week 18
Title
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
Description
Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Time Frame
baseline and week 18
Title
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
Description
Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Time Frame
baseline and week 18
Title
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
Description
Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Time Frame
baseline and week 18
Title
Clinical Global Impression - Global Improvement (CGI-I) Responder
Description
CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)
Time Frame
after 18 weeks of treatment
Title
Response in Patient Global Impression (PGI-I)
Description
PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)
Time Frame
after 18 weeks of treatment
Title
Change From Baseline in UPDRS I Score After 18 Weeks
Description
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Time Frame
baseline and 18 weeks
Title
Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period
Description
UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.
Time Frame
baseline and 18 weeks
Title
Change From Baseline in UPDRS III Score After 18 Weeks
Description
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Time Frame
baseline and 18 weeks
Title
Change From Baseline in UPDRS IV Score After 18 Weeks
Description
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Time Frame
baseline and 18 weeks
Title
Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks
Description
ranging from 0 (best case) to 63 (worst case)
Time Frame
baseline and 18 weeks
Title
Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks
Description
ranging from 0 (worst case) to 150 (best case)
Time Frame
baseline and 18 weeks
Title
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks
Description
Ranging from 0 (best case) to 156 (worst case)
Time Frame
baseline and 18 weeks
Title
Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks
Description
ranging from 0 (worst case) to 100 (best case)
Time Frame
baseline and 18 weeks
Title
Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18
Description
Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".
Time Frame
baseline and week 18
Title
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Time Frame
baseline and week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. Parkinsons disease diagnosed for at least 2 years. Patients 30 years of age or older at the time of diagnosis. Modified Hoehn and Yahr stage of 2 to 4 at on-time. Treatment with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor, or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit). Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation). Exclusion Criteria: Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study History of psychosis, except history of drug induced hallucinations History of deep brain stimulation Clinically significant Electrocardiogram abnormalities at screening visit Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit Malignant melanoma or history of previously treated malignant melanoma Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study Pregnancy or breast-feeding Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study period Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal Patients with a creatinine clearance < 50 millilitres/minute Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines Flunarizine within 3 months prior to baseline visit Known hypersensitivity to pramipexole or its excipients Drug abuse according to investigators judgement, within 2 years prior to screening Participation in other investigational drug studies, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
248.525.43005 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
248.525.42003 Boehringer Ingelheim Investigational Site
City
Pardubice
Country
Czech Republic
Facility Name
248.525.42001 Boehringer Ingelheim Investigational Site
City
Praha
Country
Czech Republic
Facility Name
248.525.42005 Boehringer Ingelheim Investigational Site
City
Rakovnik
Country
Czech Republic
Facility Name
248.525.42002 Boehringer Ingelheim Investigational Site
City
Rychnov nad Kneznou
Country
Czech Republic
Facility Name
248.525.42004 Boehringer Ingelheim Investigational Site
City
Valasske Mezirici
Country
Czech Republic
Facility Name
248.525.36005 Boehringer Ingelheim Investigational Site
City
Györ
Country
Hungary
Facility Name
248.525.36003 Boehringer Ingelheim Investigational Site
City
Kecskemét
Country
Hungary
Facility Name
248.525.36006 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
248.525.36004 Boehringer Ingelheim Investigational Site
City
Veszprem
Country
Hungary
Facility Name
248.525.91004 National Institute of Mental Health & Neuro Sciences
City
Bangalore
Country
India
Facility Name
248.525.91002 Apollo Hospital
City
Chennai
Country
India
Facility Name
248.525.91001 Institute of Human Behaviour & Allied Sciences
City
Delhi
Country
India
Facility Name
248.525.91003 Nizam's Institute of Medical Sciences
City
Hyderabad
Country
India
Facility Name
248.525.91007 Boehringer Ingelheim Investigational Site
City
Indore
Country
India
Facility Name
248.525.91005 Mallikatta Neuro Research Center
City
Karnataka
Country
India
Facility Name
248.525.91006 King Edward Memorial Hospital & Research Centre
City
Pune
Country
India
Facility Name
248.525.39001 Policlinico di Catania
City
Catania
Country
Italy
Facility Name
248.525.39010 Campus Universitario Germaneto
City
Catanzaro
Country
Italy
Facility Name
248.525.39009 Ce.S.I.
City
Chieti
Country
Italy
Facility Name
248.525.39007 Ospedale della Misericordia
City
Grosseto
Country
Italy
Facility Name
248.525.39002 Università Federico II
City
Napoli
Country
Italy
Facility Name
248.525.39008 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
City
Pisa
Country
Italy
Facility Name
248.525.39005 Università La Sapienza di Roma
City
Roma
Country
Italy
Facility Name
248.525.39011 Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
248.525.82001 Boehringer Ingelheim Investigational Site
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
248.525.82008 Boehringer Ingelheim Investigational Site
City
Kyeonggi-do
Country
Korea, Republic of
Facility Name
248.525.82007 Boehringer Ingelheim Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
248.525.82002 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
248.525.82003 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
248.525.82004 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
248.525.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
248.525.82006 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
248.525.63210 Makati Medical Center
City
Makati City
Country
Philippines
Facility Name
248.525.63202 Chinese General Hospital
City
Manila
Country
Philippines
Facility Name
248.525.63205 Jose Reyes Memorial Medical Center
City
Manila
Country
Philippines
Facility Name
248.525.63206 Metropolitan Medical Center
City
Manila
Country
Philippines
Facility Name
248.525.63207 Manila Doctors Hospital
City
Manila
Country
Philippines
Facility Name
248.525.63201 The Medical City
City
Pasig
Country
Philippines
Facility Name
248.525.63204 St Lukes Medical Center
City
Quezon
Country
Philippines
Facility Name
248.525.63208 University of the East Ramon Magsaysay Memorial Medical Ctr
City
Quezon
Country
Philippines
Facility Name
248.525.48001 Boehringer Ingelheim Investigational Site
City
Gdansk
Country
Poland
Facility Name
248.525.48003 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
248.525.48002 Wolski Hospital Dr. Anna Gostynska
City
Warsaw
Country
Poland
Facility Name
248.525.07001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.525.07002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.525.07003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.525.07004 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.525.07007 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.525.07005 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
248.525.07006 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
248.525.42104 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
248.525.42105 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
248.525.42103 Boehringer Ingelheim Investigational Site
City
Dubnica nad Vahom
Country
Slovakia
Facility Name
248.525.42101 Boehringer Ingelheim Investigational Site
City
Trnava
Country
Slovakia
Facility Name
248.525.34001 Boehringer Ingelheim Investigational Site
City
Alcorcon (Madrid)
Country
Spain
Facility Name
248.525.34003 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
248.525.34004 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
248.525.34005 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
248.525.34002 Boehringer Ingelheim Investigational Site
City
San Cugat del Valles (Barcelona)
Country
Spain
Facility Name
248.525.34008 Boehringer Ingelheim Investigational Site
City
Tarrasa (Barcelona)
Country
Spain
Facility Name
248.525.46005 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
248.525.46002 Boehringer Ingelheim Investigational Site
City
Nyköping
Country
Sweden
Facility Name
248.525.46001 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
248.525.46004 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
248.525.38003 Boehringer Ingelheim Investigational Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
248.525.38006 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
248.525.38002 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
248.525.38004 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
248.525.38005 Boehringer Ingelheim Investigational Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
248.525.38001 Boehringer Ingelheim Investigational Site
City
Zaporozhye
Country
Ukraine
Facility Name
248.525.44005 Boehringer Ingelheim Investigational Site
City
Barnsley
Country
United Kingdom
Facility Name
248.525.44007 Boehringer Ingelheim Investigational Site
City
Blackburn
Country
United Kingdom
Facility Name
248.525.44002 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
248.525.44004 Boehringer Ingelheim Investigational Site
City
Norwich
Country
United Kingdom
Facility Name
248.525.44003 Boehringer Ingelheim Investigational Site
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.525_U09-1270-04-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.525_literature.pdf
Description
Related Info

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Pivotal Study in Advanced Parkinsons Disease Patients

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